Relypsa Presents Veltassa Data for Hyperkalemia at 53rd European Renal Association Congress

Relypsa Presents Veltassa Data for Hyperkalemia at 53rd European Renal Association Congress

The biopharmacuetical company Relypsa, during the recent 53rd Congress of the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA), presented new data from studies evaluating the company’s Veltassa (patiromer) for hyperkalemia.

“Patients with heart failure and chronic kidney disease often have restricted fluid and sodium intake, as these may cause congestive symptoms. We presented new data suggesting Veltassa may bind and remove sodium as well as potassium in the gastrointestinal tract, which may be relevant for these patients,” said Dr. Lance Berman, chief medical officer of Relypsa in a press release.

Hyperkalemia, or elevated blood potassium levels, is a potentially life-threatening condition predominantly seen in patients treated with renin-angiotensin-aldosterone system (RAAS) inhibitors with stage 3 or greater chronic kidney disease (CKD), and who might also struggle with diabetes, heart failure, or both.

Berman said a separate analysis showed that Velatassa controlled potassium levels for up to a year in hyperkalemic patients who were taking multiple blood pressure medicines.

“This is important because the use of certain types of blood pressure medicine is often limited due to the side effect of hyperkalemia,” Berman said.

In the first presentation, “Effect of the Potassium Binding Polymer Patiromer on Urine Sodium Excretion in Healthy Adults,” Dr. David A. Bushinsky reported the results of the Phase 1 RLY5016-101 trial, which assessed sodium change in urine from 32 healthy patients taking Veltassa for eight days.

The data showed that treatment with Veltassa caused a dose-related reduction in mean urine sodium compared with placebo. The worst side effects were gastrointestinal reactions.

In a second presentation, “Effect of Patiromer for Up to 52 Weeks in Patients with Diabetic Kidney Disease Receiving Combined RAAS Inhibitor Therapy,” Dr. Alain Romero reported the post-hoc analysis results of the AMETHYST-DN trial which examined Veltassa over a 52-week interval.  Hyperkalemic patients in that trial had with CKD and type 2 diabetes, and were taking renin angiotensin aldosterone system (RAAS) inhibitors.

The effect of Veltassa on the levels of blood potassium was examined in 56 patients with hyperkalemia who were being treated with two RAAS inhibitors for hypertension. Of those, 31 patients were treated with an ACE inhibitor and an ARB and 25 were being treated with a combined therapy consisting of an ACE inhibitor and/or an ARB and a mineralocorticoid antagonist.

The results revealed that in those with mild or moderate hyperkalemia, Veltassa treatment decreased the mean blood potassium levels from baseline, with the effect lasting throughout the 52-week study period. During the same time, 23% of patients reported one or more Veltassa-related adverse events, the most common being constipation and diarrhea. Less than 9% stopped the study because of adverse reactions.

Patiromer for oral suspension is an FDA-approved orally administered drug being investigated now for the treatment of hyperkalemia.

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